Actively Recruiting
Phase 1 Study of Ziftomenib with Venetoclax/Azacitidine or Standard Induction Chemotherapy in Patients With Acute Myeloid Leukemia
Led by Kura Oncology, Inc. · Updated on 2026-03-13
420
Participants Needed
44
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ziftomenib, an investigational oral drug, in combination with standard treatments for patients with acute myeloid leukemia (AML) who have specific genetic mutations such as NPM1 or KMT2A rearrangements. This Phase 1 trial aims to assess the safety, tolerability, and early signs of effectiveness of ziftomenib when added to existing AML therapies in both newly diagnosed and relapsed/refractory patients. The study includes several treatment groups where ziftomenib is combined with drugs like venetoclax, azacitidine, daunorubicin, cytarabine, and quizartinib. Patients receive these medications through oral, intravenous, or subcutaneous routes depending on the combination. Different arms focus on distinct patient groups based on genetic markers and prior treatment history. The study investigates dose levels and combinations including intensive chemotherapy regimens and targeted therapies over multiple treatment cycles. Participants will be monitored closely from the first day of treatment through up to 36 months, with regular assessments of side effects, blood tests, and response to therapy including remission rates. Researchers will track dose-limiting toxicities and adverse events, as well as disease outcomes like complete remission and measurable residual disease. Safety and effectiveness data will be collected through a series of treatment cycles, with follow-up continuing for up to three years to evaluate long-term impact and survival outcomes.
CONDITIONS
Brief Title
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a documented NPM1 mutation or KMT2A rearrangement with newly diagnosed or relapsed/refractory AML
- Patients intending intensive chemotherapy in Arm C should be NPM1 mutated and FLT3-ITD positive with allelic ratio 650.05 and eligible for FLT3-targeted treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Adequate liver, kidney, and heart function as defined by the protocol
- Females of childbearing potential must agree to use adequate contraception and a double barrier method from screening through 180 days after last dose
- Males of childbearing potential must agree to abstinence or use a double barrier method of contraception from screening through 180 days after last dose
- Females receiving quizartinib in Arm C must use a highly effective contraception during treatment and for 7 months after last dose
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia or blast phase chronic myeloid leukemia
- Known history of BCR-ABL alteration
- Advanced malignant liver tumor
- Receipt of live attenuated vaccines within 14 days before, during, or after treatment until B-cell recovery
- Active central nervous system involvement by AML
- Clinical signs or symptoms of leukostasis or white blood cell count over 25,000/microliter (except controlled by permitted treatments)
- Not recovered to Grade 641 from non-blood toxicities except hair loss
- Known active HIV, hepatitis B, or hepatitis C infection
- Prior chemotherapy for leukemia in newly diagnosed cohorts except specified treatments
- Investigational therapies within 14 days or 5 drug half-lives before first dose in relapsed/refractory cohorts
- Uncontrolled illnesses including cardiac conditions defined by protocol
- Prolonged QT interval over limits on ECGs specific to treatment arms
- Uncontrolled infection
- Pregnant or lactating women
- Active malignancy under chemotherapy or uncontrolled/progressing disease
- Active graft versus host disease requiring high-dose prednisone or recent increase in immunosuppressants within 2 weeks prior to study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months or until relapse, new anti-cancer therapy, death, or treatment discontinuation
Participants receive treatment with Ziftomenib in combination with Venetoclax/Azacitidine, Venetoclax, 7+3 chemotherapy, or 7+3+Quizartinib according to their assigned group.
Visits occur throughout each 28-day treatment cycle with assessments during and after treatment cycles
Duration - Up to 1 year following the start of treatment
Participants are monitored for safety, remission status, and long-term outcomes after treatment ends.
Periodic follow-up visits as scheduled by the study team
Trial Site Locations
Total: 44 locations
1
Mayo Clinic - Phoenix
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Moores UC San Diego Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
UCLA - Bowyer Oncology Center
Los Angeles, California, United States, 90095
Actively Recruiting
5
UC Irvine Health Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
6
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
8
Yale Cancer Center and Smilow Cancer Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
9
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
10
Emory Healthcare - The Emory Clinic
Atlanta, Georgia, United States, 30308
Actively Recruiting
11
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
12
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
13
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
14
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
15
The University of Kansas Medical Center Research Institute
Fairway, Kansas, United States, 66205
Actively Recruiting
16
University of Kentucky Markey Cancer Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
17
Norton Cancer Institute - St. Matthews
Louisville, Kentucky, United States, 40207
Actively Recruiting
18
Ochsner MD Anderson Cancer Center
Jefferson, Louisiana, United States, 70121
Actively Recruiting
19
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
Actively Recruiting
20
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
21
UMass Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
22
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
23
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
24
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
25
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
26
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
27
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
28
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14203
Actively Recruiting
29
New York - Presbyterian / Weill Cornell Medicine
New York, New York, United States, 10021
Actively Recruiting
30
Mount Sinai - Ruttenberg Treatment Center
New York, New York, United States, 10029
Actively Recruiting
31
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
32
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
33
Duke Blood Cancer Center
Durham, North Carolina, United States, 27705
Actively Recruiting
34
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
35
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States, 44195
Actively Recruiting
36
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
Actively Recruiting
37
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
38
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
39
TriStar Bone Marrow Transplant
Nashville, Tennessee, United States, 37203
Actively Recruiting
40
Sarah Cannon Research Institute - St. David's South Austin Medical Center / Texas Oncology South Austin
Austin, Texas, United States, 78704
Actively Recruiting
41
UT Southwestern - Simmons Cancer Center
Dallas, Texas, United States, 75235
Actively Recruiting
42
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
43
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Actively Recruiting
44
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
K
Kura Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
13
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